Endoscopic fundoplication devices and methods for treatment of gastroesophageal reflux disease

ABSTRACT

Endoscopic devices and methods used for fastening multiple tissue layers, such as, for example, an endoscopic fundoplication procedure, are disclosed. The endoluminal device includes a tissue fastener, a flexible needle having means for grasping and releasing a portion of the tissue fastener, and a deflector for deflecting and guiding the needle toward the multiple tissue layers.

FIELD OF THE INVENTION

The present invention relates to endoscopic devices and related methods.In particular, the present invention relates to endoscopic devices andmethods used in, for example, an endoscopic fundoplication procedure fortreatment of Gastroesophageal Reflux Disease (GERD).

BACKGROUND OF THE INVENTION

Gastroesophageal reflux occurs when stomach acid enters the esophagus.This reflux of acid into the esophagus occurs naturally in healthyindividuals, but also may become a pathological condition in others.Effects from gastroesophageal reflux range from mild to severe. Mildeffects include heartburn, a burning sensation experienced behind thebreastbone. More severe effects include a variety of complications, suchas esophageal erosion, esophageal ulcers, esophageal stricture, abnormalepithelium (e.g., Barrett's esophagus), and/or pulmonary aspiration.These various clinical conditions and changes in tissue structure thatresult from reflux of stomach acid into the esophagus are referred togenerally as Gastroesophageal Reflux Disease (GERD).

Many mechanisms contribute to prevent gastroesophageal reflux in healthyindividuals. One such mechanism is the functioning of the loweresophageal sphincter (LES). With reference to FIG. 1A, the LES 2 is aring of smooth muscle and increased annular thickness existing inapproximately the last four centimeters of the esophagus. In its restingstate, the LES creates a region of high pressure (approximately 15-30 mmHg above intragastric pressure) at the opening of the esophagus 3 intothe stomach 7. This pressure essentially closes the esophagus 3 so thatcontents of the stomach cannot pass back into the esophagus 3. The LES 2opens in response to swallowing and peristaltic motion in the esophagus,allowing food to pass into the stomach. After opening, however, aproperly functioning LES 2 should return to the resting, or closedstate. Transient relaxations of the LES 2 do occur in healthyindividuals, typically resulting in occasional bouts of heartburn.

The physical interaction occurring between the gastric fundus 5 and theesophagus 3 also prevents gastroesophageal reflux. The gastric fundus 5is a lobe of the stomach situated at the top of the stomach 7 distal tothe esophagus 3. In asymptomatic individuals, the fundus 5 pressesagainst the opening of the esophagus 3 when the stomach 7 is full offood and/or gas. This effectively closes off the esophageal opening tothe stomach 7 and helps to prevent acid reflux back into the esophagus3. More specifically, as the food bolus is immersed in gastric acid, itreleases gas which causes the fundus 5 of the stomach 7 to expand andthereby exert pressure on the distal esophagus 3 causing it to collapse.The collapse of the esophagus lumen reduces the space for the stomachacid to splash past the closed esophagus lumen and thereby protect theproximal esophagus from its destructive contact.

In individuals with GERD, the LES 2 functions abnormally, either due toan increase in transient LES relaxations, decreased muscle tone of theLES 2 during resting, or an inability of the esophageal tissue to resistinjury or repair itself after injury. These conditions often areexacerbated by overeating, intake of caffeine, chocolate or fatty foods,smoking, and/or hiatal hernia. Avoiding these exacerbating mechanismshelps curb the negative side effects associated with GERD, but does notchange the underlying disease mechanism.

A surgical procedure, known generally as fundoplication, has beendeveloped to prevent acid reflux in patients whose normal LESfunctioning, has been impaired, either as a result of GERD or otheradverse effects. This procedure involves bringing the fundus wall 6 intocloser proximity of the esophageal wall 4 to help close off theesophageal opening into the stomach 7, as shown in FIG. 1B.Traditionally, this procedure has been performed as an open surgery, butalso has been performed laparoscopically.

As with any surgery, the attendant risks are great. Due to relativelylarge incisions necessary in the performance of open surgery, relativelylarge amount of blood is lost, the risk of infection increases, and thepotential for post-operative hernias is high. Further, the relativelylarge incisions necessary in the performance of open surgery requireextended recovery times for the incision to heal.

A laparoscopic procedure may involve performing laparotomies for trocarports (penetrations of the abdominal wall), percutaneous endoscopicgastronomies (incisions through the skin into the stomach), and theinstallation of ports through which, for example, a stapler, anendoscope, and an esophageal manipulator (invagination device) areinserted. Under view of the endoscope, the esophageal manipulator isused to pull the interior of the esophagus 3 into the stomach 7. Whenthe esophagus is in position, with the fundus 5 of the stomach plicated,the stapler is moved into position around the lower end of the esophagusand the plicated fundus is stapled to the esophagus 3. The process maybe repeated at different axial and rotary positions until the desiredfundoplication is achieved. This procedure is still relatively invasiverequiring incisions through the stomach, which has a risk of infection.The location of the incision in the abdominal wall presents a risk ofother negative effects, such as sepsis, which can be caused by leakageof septic fluid contained in the stomach.

SUMMARY OF THE INVENTION

Therefore, it is accordingly an object of the present invention toprovide less invasive devices and methods for performing thefundoplication procedure. This is achieved by utilizing tissue fastenersand related deployment systems which can be endoluminally deliveredthrough the esophagus, thereby eliminating the need for highly invasive,physiologically insulting surgical procedures.

To attain the advantages and in accordance with the purpose of theinvention, as embodied and broadly described herein, one aspect of theinvention provides an endoluminal surgical device for fastening multipletissue layers. The device includes a tissue fastener, a flexible needlehaving means for grasping and releasing a portion of the tissuefastener, and a deflector for deflecting and guiding the needle towardthe multiple tissue layers.

Another aspect of the present invention is to provide a tissue fastenerused to join multiple tissue layers. The tissue fastener includes aflexible suture having a distal end and a proximal end, and a lockingmechanism configured to interconnect the distal end and the proximal endto form the suture into a closed loop.

In yet another aspect of the present invention, a tissue fastener usedto join multiple tissue layers is provided. The tissue fastener includesa connecting member, a distal fastening member, and a proximal fasteningmember. The distal fastening member is fixedly coupled to a distalportion of the connecting member, and the proximal fastening member ismoveably coupled to the connecting member proximate a proximal portionof the connecting member. After the multiple tissue layers are placedbetween the distal and proximal fastening members, the proximalfastening member is moved relative to the connecting member to adjust atension of the tissue fastener.

In still another aspect of the present invention, a method of fasteningmultiple tissue layers using a tissue fastener having a distal end and aproximal end is provided. The method includes providing a needle havinga sharp distal end, attaching the distal end of the tissue fastener tothe needle, passing the needle and the distal end of the tissue fastenerthrough a first location of the tissue layers from a first side of thetissue layers to a second side of the tissue layers, while keeping theproximal end of the suture on the first side, releasing the distal endof the tissue fastener from the needle, withdrawing the needle throughthe tissue layers, passing the needle to the second side through asecond location of the tissue layers, attaching the distal end of thetissue fastener to the needle, withdrawing the needle and the distal endof the tissue fastener through the tissue layers to the first side, andinterconnecting the distal end and the proximal end of the tissuefastener to form a closed loop.

In still another aspect of the present invention, a method of fasteningmultiple tissue layers using a tissue fastener having a distal member, aproximal member, and a connecting member connecting the distal andproximal members, is provided. The method includes extending a tubewithin the multiple tissue layers from a first side of the tissue layersto a second side of the tissue layers, placing a tissue fastener insidethe tube, passing the distal member of the tissue fastener to the secondside through the tube while holding the proximal member on the firstside, expanding the distal member against a surface of the tissuelayers, and exposing the proximal member out of the tube on the firstside, and expanding the proximal member against a surface of themultiple tissue layers.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims.

It is to be understood that both the foregoing general description andthe following detailed description are exemplary and explanatory onlyand are not restrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate several embodiments of theinvention and together with the description, serve to explain theprinciples of the invention.

In the drawings:

FIG. 1A is a cross-sectional view of the gastrointestinal tract in theregion of the lower esophageal sphincter (LES) and the fundus of thestomach;

FIG. 1B is a cross-sectional view of the gastrointestinal tract in theregion of the lower esophageal sphincter (LES) and the fundus of thestomach, after a fundoplication procedure is performed;

FIG. 2 is a perspective view of a distal portion of an endoscopicfundoplication device, according to an embodiment of the presentinvention;

FIGS. 3A-3B are perspective views of a needle basket, according to anembodiment of the present invention, illustrating operational steps forgrasping a distal end of a suture;

FIG. 4A-4C are perspective views of a needle basket, according toanother embodiment of the present invention, illustrating operationalsteps for grasping a distal end of a suture;

FIG. 5A-5B are perspective views of biopsy forceps used as a needlebasket, according to still another embodiment of the present invention,illustrating FINNEGAN operational steps for grasping a distal end of asuture;

FIG. 6 is a perspective view of a tissue fastener according to anembodiment of the present invention;

FIGS. 7-9 are schematic illustration of a deflector, a needle basket,and a tissue fastener arrangement, according to an embodiment of thepresent invention;

FIGS. 10-12 are schematic illustration of a deflector, a needle basket,and a tissue fastener arrangement, according to another embodiment ofthe present invention;

FIGS. 13-16 are schematic illustrations of the endoscopic fundoplicationdevice shown in FIG. 2 in the gastro-esophageal junction, showingoperational procedures for creating a plicated fold, according to anembodiment of the present invention;

FIGS. 17-22 are schematic illustrations of a method of fasteningmultiple tissue layers, according to an embodiment of the presentinvention;

FIG. 23 is a cross sectional view of two layers of tissue, with a tissuefastener in place, according to an embodiment of the present invention;

FIG. 24 is a cross sectional view of two layers of tissue, with a tissuefastener in place, according to another embodiment of the presentinvention; and

FIGS. 25-32 are schematic illustrations of a method of fasteningmultiple tissue layers, according to another embodiment of the presentinvention.

DESCRIPTION OF THE EMBODIMENTS

Reference will now be made in detail to the exemplary embodiments of theinvention, examples of which are illustrated in the accompanyingdrawings. Wherever possible, the same reference numbers will be usedthroughout the drawings to refer to the same or like parts.

A newly developed form of fundoplication, referred to as endoscopicfundoplication, is an endoluminal procedure in which the fundus wall 6is folded back onto the esophagus wall 4, as shown in FIG. 18. Thetissue fold 1 formed between the esophagus 3 and the fundus 5 then issecured. Endoscopic fundoplication is intended to be performed as anendoluminal procedure in which insertion of required medical instrumentsoccurs through the esophagus 3. Such a procedure has the benefits ofbeing less invasive, quicker, and less expensive as compared to previoustechniques.

FIG. 2 shows a distal portion of an exemplary endoluminal surgicaldevice 10 employed in, for example, a fundoplication procedure,according to an embodiment of the present invention. The device 10includes a flexible tube 120 that can extend from outside of a body to asite deep within the body. The tube 120 is a relatively flexiblemultilumened tube, designed to encompass various operating devices, suchas, for example, endoscopes and graspers, and related cables formanipulating the operating devices. The tube 120 provides sufficientflexibility for traversing through tortuous paths within the body, forexample, to the grastroesophageal junction site.

As shown in FIG. 2, the endoluminal device 10 includes A-frame head 100coupled to a distal portion of the tube 120. A-frame head 100 is arelatively short cylindrical tube with a folding arm 110, a proximal end112 of which is pivotally connected to a distal end of the A-frame head100. The folding arm 110 is rotatable with respect to a pivot member130, such that, in a contracted state, the folding arm 110 is folded inflush with an outer surface of the A-frame head 100 and, in an extendedstate, the folding arm 110 rotatably extends to receive multiple tissuelayers to be folded between the folding arm 110 and the side surface ofthe A-frame head 100. For example, the A-frame 100 with the folding arm110 is configured to fold the gastric fundus wall 6 proximate to theesophageal wall 4 to make application fold 1. The folding arm 110 has anopening 115 or a slot along its length to permit passage of a needlebasket 170 and a tissue fastener 200. Wires, cables, or other suitablemechanisms (not shown) for manipulating the folding arm 110 run throughlumens of the tube 120. The proximal end of that mechanism connects toany suitable actuator known in the art at the proximal end of device 10.Preferably, an endoscope (not shown) is placed proximate to the A-framehead 100 for viewing. The device 10 may also include a grasper device(not shown) configured to grasp the esophageal wall 4 during the foldingprocess to prevent possible tissue movement. Preferably, the grasperdevice is a suction grasper having a suction cup positioned inside theA-frame head 100. The suction grasper device uses an air suctionmechanism to grasp the esophageal wall 4. Any other conventionally knownfundoplication devices that may be used in conjunction with device 10 toaid in the fundoplication procedure, such as those described in U.S.Pat. No. 6,086,600, the disclosure of which is hereby incorporated byreference, may be utilized.

During delivery, the A-frame head 100 is preferably covered with aA-frame protection device (not shown) formed of a thin membrane tubing.The protection device has a through opening for an endoscope to protrudeand move forward from the distal end of the A-frame head 100. Theprotection device protects the esophageal wall 4 from possible damageduring delivery.

The endoluminal device 10 further includes a long, catheter-likedeflector 150 disposed inside the tube 120. Preferably, a proximal end(not shown) of the deflector 150 extends outside of a body to facilitatemanipulation of the deflector 150. Any suitable actuation device knownin the art may be employed at the proximal end of deflector 150. Thedeflector 150 is configured to move axially within the A-frame head 100via a slot 105 formed in the A-frame head 100 in the axial direction.The deflector 150 includes a conduit 157 formed inside the deflector150, which extends substantially axially within the deflector 150 to theoutside of the body. The conduit 157 provides a path within thedeflector 150 through which a needle basket 170 moves relative to thedeflector 150. The conduit 157 is curved in the distal portion of thedeflector 150, substantially perpendicular to the side surface 151 ofthe deflector 150, as shown in FIG. 7, such that the needle basket 170is guided to exit the deflector 150 through a side opening 155 formed onthe side surface 151 of the deflector 150. It should be understood thatthe conduit 157 may be curved by more or less than 90° angle, dependingon the direction to which the needle basket 170 is desired to bedeflected.

The needle basket 170 used for perforating through multiple tissuelayers is substantially flexible, yet rigid enough to penetrate throughthe multiple tissue layers, and includes a sharp cutting edge 175 and/ora needle point 176 at its distal end. Preferably, a proximal end (notshown) of the needle basket 170 extends to outside a body to facilitatemovement of the needle basket 170 relative to the deflector 150. Anysuitable actuator known in the art may be employed at the proximal endof the device 10 to move the needle basket 170.

The needle basket 170 includes means for grasping and releasing thedistal end 290 of a suture 250, located proximate the distal end of theneedle basket 170. FIGS. 3A-3B show a portion of the needle basket 170having means for grasping and releasing the distal end 290 of a suture250, according to an embodiment of the present invention. In thisembodiment, the means for grasping and releasing includes a suction hole172 and a suction conduit 173 formed inside the hollow needle basket170. Similar to the suction grasper device described above, the needlebasket 170 uses air suction mechanism to draw the distal end 290 of thesuture 150 inside the suction hole 172. Preferably, the proximal end ofthe needle basket 170 is connected to a suitable suction device (notshown). By turning on and off the suction device, the distal end 290 ofthe suture 250 can be easily grasped or released.

FIGS. 4A-4C show a needle basket 270 having a basket type grasping andreleasing means, according to another embodiment of the presentinvention. The needle basket 270 includes a distal portion 270 a and aproximal portion 270 b, interconnected by an actuation wire 272 and aplurality of basket wires 273. The actuation wire 272 is fixedlyattached to the distal portion 270 a and axially moveable relative tothe proximal portion 270 b of the needle basket 270 to cause axialmovement of the distal portion 270 a with respect to the proximalportion 270 b. The actuation wire 272 is substantially flexible, yetrigid enough to move the distal portion 270 a of the needle basket 270without bending. The basket wires 273 are also made of flexible andrigid material, yet made less rigid than the actuation wire 272.Preferably, the basket wires 273 are formed of shape memory materials.As shown in FIGS. 4A and 4C, when the distal and proximal portions 270a, 270 b are separated apart by the length of the basket wires 273, thebasket wires 273 form substantially straight wires that are alignedsubstantially parallel to each other. The space between the basket wires273 at this stage is smaller than the cross-sectional area of the suturedistal end 290. As shown in FIG. 4B, when the distal and proximalportions 270 a, 270 b of the needle basket 270 are moved toward eachother by pulling the actuation wire 272, the basket wires 273 are bentoutwardly and widen the space between the basket wires 273, permittingthe distal end 290 of the suture 250 to enter the space. At this point,the distal and proximal portions 270 a, 270 b of the needle basket 270are then again separated apart so that the distal end 290 of the suture250 is firmly secured inside the cylindrical space formed by theplurality of basket wires 273.

FIGS. 5A-5B show biopsy forceps used as a needle basket 370, accordingto still another embodiment of the present invention. The needle basket370 includes a pair of biopsy jaws 374 a, 374 b, joined together by apivot pin 373 and positioned at the distal end of a flexible elongatedtubular member 376. The distal end portion of the tubular member 376 isfreely moveable with respect to a main body portion of the tubularmember 376 and preferably deflectable in different angles, as shown inFIG. 5B. When the pair of biopsy jaws 374 a, 374 b are closed, as shownin FIG. 5A, the needle basket 370 forms a sharp cutting edge 375 on itsdistal end for perforating multiple tissue layers. The jaws 374 a, 374 bcan be closed and opened to grasp and release the distal end 290 of thesuture 250 by suitable actuation means employable at the proximal end ofthe tubular member 376.

It should be understood that any other needle basket designs havingsimilar configuration may be utilized for the needle basket 170, suchas, for example, baskets used in stone treatment or a flexible trocartube.

The side opening 155 of deflector 150 is configured to receive a tissuefastener 200, as shown in FIG. 8. FIG. 6 shows a tissue fastener 200according to an embodiment of the present invention. The tissue fastener200 includes a flexible suture 250 or tube with a locking mechanism 220fixedly attached to the proximal end 210 of the suture 250. Preferably,the tissue fastener 200 may be formed of synthetic materials, such asABS, polystyrene, polyurethane, PLLA, PLGA, nylon, and teflon. Thetissue fastener can be made of biodegradable, bioresorbable, and/orbioabsorbable material, such that, as the fastener degrades, scar tissueforms and holds the tissue layers together. This erosion can occur in acontrolled fashion by carefully selecting a material with apredetermined degradation rate. The bioabsorbable material may be formedof cross-linked polymer networks that can be manufactured to beresponsive to body temperature, light, pH, and/or a number of otherexternal/internal stimuli.

The suture 250 includes a plurality of locking flanges 260, preferably,spaced uniformly apart. When the suture 250 with the locking flanges 260is inserted into the locking mechanism 220, the locking flange 260 islocked with the locking mechanism 220 to form a closed suture loop, asshown in FIG. 6. Preferably, the locking flanges 260 are configured topermit movement only in one direction when one of the locking flanges260 is engaged with the locking mechanism 220. Movement of the suture250 in one direction allows the adjustment of the fastening tension ofthe suture for fastening multiple tissue layers, while preventingundesirable loosening or release of the suture 250 from the lockingmechanism 220. In addition to providing a locking function, the lockingflanges 260 provide enhanced friction, preferably in one direction, whenthe suture 250 is placed within the tissue layers, such that the suture250 is not easily dislocated. In this particular embodiment, eachlocking flange 260 is formed of a skirt-like or frustoconical-shapedratchet 260. Preferably, each of the locking flanges 260 is defined by aslanted side surface 261 to provide the locking function and theenhanced friction, discussed above. Preferably, a proximal end of thelocking mechanism 220 includes a plurality of slits 225 for providingthe proximal end with a enhanced flexibility during, placement in theopening 155 of the deflector 150. In particular, when the lockingmechanism 220 is placed in the opening 155, the proximal end of thelocking mechanism 220 is flexibly deformed to fit into the opening 155,while exerting an expansion force that makes the proximal end of thelocking mechanism 220 stay in place within the opening 155. However, itshould be understood that any other suitable designs of the lockingflanges and the locking mechanism, which provide similar functions, maybe utilized.

With reference to FIGS. 7-9, operation of the needle basket 170 inconnection with a deflector 150, according to an embodiment of thepresent invention, is discussed herein. For illustration purpose, theneedle basket 170 shown in FIGS. 3A-3B is used to describe its operationin connection with the deflector 150. It should be understood, however,that other embodiments of the needle baskets 270, 370 shown in FIGS.4A-4C and 5A-5B, respectively, can also be used in similar mannerdescribed herein. As shown in FIG. 7, the deflector 150 includes aconduit 157 formed inside the deflector 150, through which a needlebasket 170 travels relative to the deflector 150. The conduit 157 isbent substantially perpendicular to the side surface 151 in the distalportion of the deflector 150. On the side surface 151 of the deflector150, an opening 155 configured to receive the tissue fastener 200 shownin FIG. 6 is formed. Any other suitable tissue fasteners with similarconfiguration may be used. As shown in FIG. 9, a flexible needle basket170 is inserted through the conduit 157 of the deflector 150. The needlebasket 170 is guided and deflected in the deflector 150 to perforatethrough multiple tissue layers. During a fundoplication procedure, forexample, the endoluminal device 10 is inserted transorally to the lowerend of the esophagus and, once the esophageal wall 4 and the fundus wall6 are folded together, the deflector 150 with the needle basket 170 isinserted through a lumen of the endoluminal device 10. The needle basket170 is then deflected inside of the deflector 150 and directed towardthe folded layers of the esophageal wall 4 and the fundus wall 6 toperform perforation through the layers.

When the needle basket 170 protrudes out of the side opening 155 andthrough the locking mechanism 220 of the tissue fastener 200, the needlebasket 170 grasps the distal loose end 290 of the suture 150 by thegrasping and releasing means, described above, and carries it throughthe multiple tissue layers, as shown in FIG. 9.

FIGS. 10-12 show a tissue fastener 300 and a deflector 450 according toanother embodiment of the present invention. As shown in the figures, adistal portion 480 of a deflector 450 is releaseably coupled to the mainbody of the deflector 450 and constitutes a portion of the tissuefastener 300. While, in this particular embodiment, the distal portion480 is coupled to the main body of the deflector 450 by a plurality oflocking protrusions 481 configured to be mated with a plurality ofrespective recesses 482, any other suitable connection means can beutilized. Preferably, the connection means also includes releasing meansto permit distal portion 480 to release from the remainder of deflector450. The distal portion 480 and the main body of the deflector 450 isconnected in such a way that a conduit 457 formed inside the main bodycommunicates with a conduit 487 formed inside the distal portion 480.The conduit 487 formed in the distal portion 480 of the deflector 450 isbent substantially perpendicular to the side surface 451, and an opening455 is formed on the side surface of the distal portion 480 of thedeflector 450. As shown in the figures, a locking mechanism 320 for thetissue fastener 300 is disposed proximate to the opening 455.Preferably, the locking mechanism 320 is integrally formed with theconduit 487 of the distal portion 480. The tissue fastener 300 includesa flexible suture 350 or tube, a distal end of which is fixedly attachedto the distal portion 480 of the deflector 450. The same type of suture250 and locking mechanism 220 depicted in the embodiment shown in FIGS.6-9 are used in this embodiment for illustration purpose and, therefore,further explanation of the suture 350 and locking mechanism 320 isomitted. It should be understood that this is, by no means, limiting andthat any other suitable designs of the tissue fasteners and relatedlocking mechanisms can be utilized.

Methods of installing the tissue fastener 200, 300, according toembodiments of the present invention, are described herein. Forillustration purpose, the method is described in connection with afundoplication procedure performed in the gastro-esophageal junction.

As shown in FIG. 13, the endoluminal device 10 including the tube 120and the A-frame head 100 is inserted transorally to thegastro-esophageal junction, preferably with proper lubrication. Theendoscope (not shown) is retroflexed in the stomach 7 to have viewing ofthe A-frame head 100. Using a manipulating device (not shown) on theproximal end of the tube 120, the folding arm 110 of the A-frame 100extends in the stomach 7 and is positioned ready for folding, as shownin FIG. 14. The suction grasper 140 is then inserted through the tube120 to an opening in the A-frame head 100 and suction force firmlygrasps the esophageal wall 4 to prevent movement during the foldingprocess, as shown in FIG. 15. The folding arm 110 then closes and foldsthe fundus wall 6 proximate to the esophagus wall 4, creating a plicatedfold 1, as shown in FIG. 16. Preferably, the suction grasper iswithdrawn from the A-frame head 100, and the deflector 150, 450containing a tissue fastener 200, 300 and a needle basket 170 isinserted through a lumen of the tube 120.

Preferably, the tissue fastener 200, 300 is loaded in the deflector 150,450, prior to the insertion. For the embodiment shown in FIGS. 7-9, thetissue fastener 200 may be loaded onto the opening 155 of the deflector150 by inserting the slitted end of the locking mechanism 220 in theopening 155 of the deflector 150. Once the locking mechanism 220 isplaced in the opening, the needle basket 170 is advanced through theconduit 157 of the deflector 150 and subsequently through the lockingmechanism 220 of the fastener 200.

After the fundus wall 6 is folded proximate to the esophagus wall 4 bythe folding arm 110, thereby creating a plicated fold 1 at thegastro-esophageal junction, the needle basket 170 is advanced throughthe conduit 157, 457, 458 of the deflector 150, 450 toward the plicatedfold of the esophageal wall 4 and the fundus wall 6, held by the foldingarm 110. FIGS. 17-24 schematically illustrate a method of fastening theplicated fold of the esophageal wall 4 and the fundus wall 6 with atissue fastener 200, 300, according to an embodiment of the presentinvention.

As shown in FIG. 17, the needle basket 170 protrudes out of thedeflector 150 and grasps the distal end 290 of the suture 250 with thegrasping and releasing means 172. The needle basket 170 then carries thedistal end 290 of the suture 250 from the esophageal side to the stomachside, as shown in FIG. 18. Once the needle basket 170 passes through theboth walls 4, 6, the needle basket 170 releases the distal end 290 ofthe suture 250 and is withdrawn back into the deflector 150, as shown inFIG. 19. The plurality of locking flanges 260 help the suture 250 remainin place within the tissue layers and, preferably, only allows movementtoward the stomach side. The deflector 150 containing the needle basket170 and the locking mechanism 220 is then moved to another positionwithin the A-frame head 100, preferably, via the slot 105 formed on theA-frame head 100, and is again advanced through the plicated fold, asillustrated by FIGS. 20 and 21. Once through to the stomach side, thegrasping and releasing means 172 in the needle basket 170 is used againto grasp the loose distal end 290 of the suture 250. By pulling theneedle basket 170 back into the deflector 150, shown in FIG. 22, thedistal end 290 of the suture 250 engages the locking mechanism 220 and aclosed loop of the tissue fastener 200 is created. By continuouslypulling the needle basket 170 and/or by withdrawing the deflector 150,the fastening tension of the tissue fastener 200 can be furthertightened. Once the desired fastening tension is achieved, the needlebasket 170 releases the suture 250 and is removed together with thedeflector 150. The installed tissue fastener 200 is shown in FIG. 23.For the tissue fastener 300 shown in FIGS. 10-12, after the tissuefastener is installed in place, the distal portion 480 of the deflector450 is detached from the main body, as shown in FIG. 24. If desired,additional tissue fasteners 200, 300 may be placed by repeating themethod described above.

Another method for installing a tissue fastener using a deflector system150, according to another aspect of the invention, is described belowwith reference to FIGS. 25-32. As shown in FIG. 25, after the funduswall 6 is folded proximate to the esophageal wall 4, a deflector 150 isinserted proximate to the plicated fold of the esophageal wall 4 and thefundus wall 6. A flexible trocar tube 600 is then inserted through theconduit 157 of the deflector 150 and is deflected toward the plicatedfold, as shown in FIG. 26. Preferably, an introducer 670 or a needlehaving a sharp cutting edge 690 and a point at its distal end isinserted through the trocar tube 600 to perforate through the plicatedfold, as shown in FIG. 27. Instead of using an introducer 670, it shouldbe recognized that the trocar tube 600 may include a sharp cutting edgeat its distal end and, thereby, eliminating the need for the introducer670.

As shown in FIG. 28, the trocar tube 600 with the introducer 670 passesthrough the plicated fold of the esophageal wall 4 and the fundus wall6. Once the trocar tube 600 passes through the plicated fold, theintroducer 670 is withdrawn from the trocar tube 600 while the trocartube 600 remains in the same place, as shown in FIG. 29. A tissuefastener 800 with its proximal end grasped by a grasper-pusher assembly700 is inserted through the trocar tube 600. The grasper-pusher assembly700 includes a grasper 710 at its distal end.

The tissue fastener 800 has a distal member 810, a proximal member 890,and a connecting member 850 connecting the distal and proximal members810, 890 to each other. Preferably, the distal member 810 and theproximal member 890 are each constructed to expand from a contractedstate to an expanded state, such that, when protruded out of the trocartube 600, each of the distal and proximal members 810, 890 expands toform a fastening member for holding the esophageal wall 4 and the funduswall 6 together. In the contracted state, the tissue fastener 800 is lowin profile to be loaded into the trocar tube 800.

In an embodiment shown in FIGS. 30-32, each of the distal and proximalmembers 810, 890 is a T-shaped fastening button connected to aconnecting member, e.g., a suture 850. While the distal member 810 isfixedly secured to a distal end of the suture 850, the proximal member890 is configured to move axially along the suture 850, so that thefastening tension can be adjusted. As shown in FIG. 31, when the distalmember 810 is advanced out of the trocar tube 600, the distal memberfalls into the stomach 7 and, when the distal member 810 is pulled backby pulling the suture 850, the T-shaped fastening button is formed andfastens the plicated fold against the fundus wall 6. Once the distalmember 810 is properly positioned, the trocar tube 600 is withdrawn,while keeping the grasper-pusher 700 in the same position, to expose theproximal member 890 out of the trocar tube 600. Similar to the distalmember 810, when the proximal member 890 is out of the trocar tube 600,the proximal member 890 extends to form a T-shaped fastening button.After the proximal fastening button 890 is formed, the grasper-pusherassembly 700 is pulled, while the trocar tube 600 pushes the proximalfastening button 890 toward the esophageal wall 4, to adjust thetightness of the tissue fastener 800, as shown in FIG. 32. Preferably,the suture 850 includes a plurality of locking members 860 associatedwith the proximal fastening button 890 for locking the button in place.The locking members 860 allow the proximal member 890 to remain inplace, and thereby prevent tissue fastener migration. Although aspecific embodiment of a tissue fastener 800 is used to illustrate amethod of fastening multiple tissue layers, it should be recognized thatany other suitable designs of tissue fasteners having the similaroperational characteristics may be utilized. Moreover, it should also berecognized that the disclosed tissue fastener 800 may be used with anyother suitable deployment mechanisms known in the art.

Once the desired fastening tension is achieved, the grasper-pusherassembly 700 releases the proximal end of the suture 850 and is removedtogether with the trocar tube 600 out of the body. The remaining portionof the suture 850 beyond the proximal fastening member 890 may be cutoff by using a suitable device. Depending on the type of tissuefasteners used and the desired fastening strength, additional tissuefasteners 800 may be placed by repeating the method described above.

Although the present invention is depicted in this disclosure as beingused in the treatment of GERD, e.g., a fundoplication procedureperformed in the gastro-esophageal junction, it is to be understood thatthe tissue fastener and related deployment methods and systems of thepresent invention can be used to treat any of a number of differentdisease conditions, and can be used for fastening any desired bodytissues.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. It is intended that the specification andexamples be considered as exemplary only, with a true scope and spiritof the invention being indicated by the following claims.

1. An endoluminal surgical device for fastening multiple tissue layers,comprising: a tissue fastener; a flexible needle having means forgrasping and releasing a portion of the tissue fastener; and a deflectorfor deflecting and guiding the needle toward the multiple tissue layers.2. The surgical device as defined in claim 1, wherein the deflectorincludes an elongated tube.
 3. The surgical device as defined in claim1, further comprising an A-frame head configured to receive thedeflector and move axially relative to the deflector.
 4. The surgicaldevice as defined in claim 3, wherein the A-frame head includes a slotfor guiding the deflector.
 5. The surgical device as defined in claim 3,wherein the A-frame head includes a foldable arm having an opening. 6.The surgical device as defined in claim 2, wherein the deflector definesa conduit therein for guiding the needle, wherein the conduit is curvedto deflect and guide the needle toward the multiple tissue layers. 7.The surgical device as defined in claim 6, wherein the conduit includesa proximal portion and a distal portion, the proximal portion extendingsubstantially axially within the deflector and the distal portion angledrelative to the proximal portion.
 8. The surgical device as defined inclaim 7, wherein the distal portion is substantially perpendicular tothe proximal portion of the deflector.
 9. The surgical device as definedin claim 7, wherein the distal portion communicates with an openingdefined by a side surface of the deflector.
 10. The surgical device asdefined in claim 7, wherein: the deflector includes a main body and adistal body releaseably connected to the main body, wherein the mainbody contains the proximal portion of the conduit and the distal bodycontains the distal portion of the conduit.
 11. The surgical device asdefined in claim 1, wherein the needle is configured to move relative tothe deflector.
 12. The surgical device as defined in claim 1, whereinthe needle includes a cutting edge at a distal end of the needle forperforating through the multiple tissue layers.
 13. The surgical deviceas defined in claim 1, wherein the deflector defines an opening in aside of the deflector configured to receive the tissue fastener and theneedle.
 14. The surgical device as defined in claim 13, wherein thetissue fastener comprises: a flexible suture having a distal end and aproximal end; and a locking mechanism for interconnecting the distal andproximal ends of the suture to form the suture into a closed loop. 15.The surgical device as defined in claim 14, wherein the tissue fastenerfurther includes means for attaching the tissue fastener to the openingof the deflector.
 16. The surgical device as defined in claim 22,wherein the attaching means includes slits in the locking mechanism. 17.The surgical device as defined in claim 23, wherein the lockingmechanism has a conical shape.
 18. The surgical device as defined inclaim 1, further comprising a flexible tube having at least one lumenand configured to extend from outside of a body to inside the body. 19.The surgical device as defined in claim 25, wherein the tube isconfigured to accommodate the tissue fastener, the flexible needle, andthe deflector inside the lumen during delivery.
 20. The surgical deviceas defined in claim 25, further comprising an A-frame head coupled to adistal portion of the tube, the A-frame head including an arm pivotallyconnected to a portion of the A-frame head and configured to receive themultiple tissue layers between the arm and a surface of the A-framehead. 21-66. (canceled)